BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 23037988 · Received September 12, 2025

    Report

    Report Number
    3013886523-2025-00244
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 17, 2025
    Report Date
    December 18, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780515593
    PMA / PMN Number
    K233448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D8, D9, G6, H1, H2, H3, H6, H8, H11. THE EVD CATHETER (ID 821745) WAS NOT RETURNED FOR EVALUATION, BUT A PHOTO WAS PROVIDED AND EVALUATED: SHOWING THE PRESENCE OF WHAT LOOKS LIKE HAIR INSIDE THE SEALED BLISTER. DEVICE HISTORY RECORD (DHR) - THE PRODUCT CODE 821745 WITH LOT 7452307 CONFORMED TO SPECIFICATIONS WHEN RELEASED TO STOCK FAILURE ANALYSIS - AFTER REVIEWING THE PHOTO PROVIDED BY THE CUSTOMER, WE CAN SEE THE PRESENCE OF WHAT LOOKS LIKE HAIR INSIDE THE SEALED BLISTER. ROOT CAUSE ANALYSIS - THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER WAS DUE TO A HUMAN ERROR. THE SPECS IN THE WORKING INSTRUCTION WERE NOT APPLIED. AN AWARENESS TRAINING WAS PERFORMED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A HAIR WAS FOUND INSIDE THE INNER STERILE PACKAGE OF AN EVD CATHETER (ID 821745). PACKAGE REMAINED SEALED AND A NEW ONE OPENED. NO SURGICAL DELAY, NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655707 CODMAN BACTISEAL EVD CATHETER BACTISEAL EVD CATHETERS JXG INTEGRA LIFESCIENCES MANSFIELD 7452307 10381780515593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown